A Revolutionary New Alzheimer’s Drug Was Just Approved by the FDA—What to Know

Alzheimer’s disease impacts nearly 6 million Americans, and more are expected to be diagnosed with the condition in the future, the says. It’s also the sixth leading cause of death in the country. There is currently no cure for the disease, but experts say having this new treatment can help patients have a better quality of life.

The trial, which included 1,795 adults between the ages of 50 and 90 who had mild cognitive impairment due to early Alzheimer’s disease or mild Alzheimer’s disease-related dementia, grouped participants into those who were assigned to receive lecanemab via IV infusion every two weeks or a placebo. The latest study—called Study 301—was a multi-center, randomized, double-blind, placebo-controlled, parallel-group study that enrolled 1,795 patients with Alzheimer’s disease. Patients were either randomly assigned to receive 10 milligrams of lecanemab every two weeks or a placebo.

The drug’s phase 3 clinical trial found that lecanemab caused infusion-related reactions in more than 26% of patients and ARIA in 12.6% of patients. More than 17% of people in the lecanemab group had brain bleeding . The actual impact on patients can vary. “For those patients who are later in their disease, it may not have a big impact,” Dr. Sachdev says. “For patients earlier in their disease, this could be a useful tool for slowing progression.”David Merrill, M.D., Ph.D.

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